Application 203314
- Type
- BLA
- Sponsor
- NOVO
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRESIBA | INSULIN DEGLUDEC | SOLUTION;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | No | No |
| 002 | TRESIBA | INSULIN DEGLUDEC | SOLUTION;SUBCUTANEOUS | 600 UNITS/3ML (200 UNITS/ML) | No | No |
| 003 | TRESIBA | INSULIN DEGLUDEC | SOLUTION;SUBCUTANEOUS | 1000 UNITS/10ML (100 UNITS/ML) | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0169-2550 | Tresiba | insulin degludec | Novo Nordisk | BLA | Current |
| 0169-2550 | Tresiba | insulin degludec injection | Novo Nordisk | BLA | Current |
| 0169-2550 | Tresiba | insulin degludec injection | Novo Nordisk | NDA | Current |
| 0169-2550 | Tresiba | insulin degludec injection | Novo Nordisk | NDA | Current |
| 0169-2660 | Tresiba | insulin degludec injection | Novo Nordisk | BLA | Current |
| 0169-2660 | Tresiba | insulin degludec | Novo Nordisk | BLA | Current |
| 0169-2660 | Tresiba | insulin degludec injection | Novo Nordisk | NDA | Current |
| 0169-2660 | Tresiba | insulin degludec injection | Novo Nordisk | NDA | Current |
| 0169-2662 | Tresiba | insulin degludec injection | Novo Nordisk | BLA | Current |
| 0169-2662 | Tresiba | insulin degludec | Novo Nordisk | BLA | Current |
| 0169-2662 | Tresiba | insulin degludec injection | Novo Nordisk | NDA | Current |
| 0169-2662 | Tresiba | insulin degludec injection | Novo Nordisk | NDA | Current |
| 50090-3491 | Tresiba | insulin degludec | A-S Medication Solutions | NDA | Current |
| 50090-3491 | Tresiba | insulin degludec | A-S Medication Solutions | NDA | Current |
| 50090-3491 | Tresiba | insulin degludec | A-S Medication Solutions | BLA | Current |
| 50090-3491 | Tresiba | insulin degludec | A-S Medication Solutions | BLA | Current |
| 73070-400 | Insulin Degludec | insulin degludec | Novo Nordisk Pharma, Inc. | BLA | Current |
| 73070-403 | Insulin Degludec | insulin degludec | Novo Nordisk Pharma, Inc. | BLA | Current |
| 73070-503 | Insulin Degludec | insulin degludec | Novo Nordisk Pharma, Inc. | BLA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 71512 | SUPPL | 2022-07-05 |
| 71511 | SUPPL | 2022-07-05 |
| 71510 | SUPPL | 2022-07-05 |
| 71509 | SUPPL | 2022-07-05 |
| 62408 | APPL | 2020-04-01 |
| 60956 | SUPPL | 2020-03-23 |
| 60955 | SUPPL | 2020-03-23 |
| 60895 | SUPPL | 2020-03-23 |
| 60894 | SUPPL | 2020-03-23 |
| 56721 | SUPPL | 2020-03-23 |
| 56554 | SUPPL | 2020-03-23 |
| 55157 | SUPPL | 2020-03-23 |
| 55149 | SUPPL | 2020-03-23 |
| 53508 | SUPPL | 2020-03-23 |
| 53462 | SUPPL | 2020-03-23 |
| 51188 | ORIG | 2020-03-23 |
| 51186 | ORIG | 2020-03-23 |
| 51183 | ORIG | 2020-03-23 |
| 51182 | ORIG | 2020-03-23 |
| 46475 | SUPPL | 2020-03-23 |
| 46234 | SUPPL | 2020-03-23 |
| 43427 | ORIG | 2020-03-23 |
| 19454 | ORIG | 2020-03-23 |
| 10195 | ORIG | 2020-03-23 |
| 62329 | SUPPL | 2018-03-26 |
| 64939 | ORIG | 1900-01-01 |
| 63076 | ORIG | 1900-01-01 |
| 63075 | ORIG | 1900-01-01 |